Caridian BCT Spectra Optia Service manual
SERVICE MANUAL
Spectra Optia
APHERESIS SYSTEM
®
Spectra Optia®Apheresis System
Service Manual
Part No. 777401-042
2011-01
©2011CaridianBCT, Inc.
CaridianBCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
USA Phone: +1.877.339.4228
Phone: +1.303.231.4357
USA Fax: +1.866.715.6768
Fax: +1.303.542.5215
CaridianBCT Europe N.V.
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: +32.2.715.05.90
Fax: +32.2.721.07.70
www.caridianbct.com
Contents
Preface ................................................................................................................. 15
1: Operational Description
Operational Description ..................................................................................................................................... 1-2
System Components ........................................................................................................................................... 1-3
Modes of Operation and Procedure States .......................................................................................................... 1-5
User Interface ..................................................................................................................................................... 1-7
Exchange Disposable Tubing Set ...................................................................................................................... 1-11
Collection Disposable Tubing Set .................................................................................................................... 1-15
Therapeutic Plasma Exchange .......................................................................................................................... 1-19
Mononuclear Cell Collection ........................................................................................................................... 1-22
Red Blood Cell Exchange Procedure Types ...................................................................................................... 1-24
RBCX Functional Description ......................................................................................................................... 1-26
2: System Description
System Description ............................................................................................................................................. 2-2
E-Box and Computer Systems ............................................................................................................................ 2-3
Control CCA ............................................................................................................................................. 2-5
Control Computer CCA ............................................................................................................................ 2-7
Control Ethernet CCA .............................................................................................................................. 2-8
Other Control Stack CCAs ........................................................................................................................ 2-9
Safety CCA .............................................................................................................................................. 2-11
Safety Computer CCA ............................................................................................................................. 2-12
Other Safety Stack CCA .......................................................................................................................... 2-14
AIM System CCAs .................................................................................................................................. 2-14
Motor Driver CCA .................................................................................................................................. 2-18
Display CCA ........................................................................................................................................... 2-26
Top Cap and Motherboard CCAs ........................................................................................................... 2-28
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Power System .......................................................................................................................................... 2-29
Cooling Fans ........................................................................................................................................... 2-32
Display System ................................................................................................................................................. 2-33
Display Assembly ..................................................................................................................................... 2-35
Pump System ................................................................................................................................................... 2-38
Pump Assembly ....................................................................................................................................... 2-41
Valve System .................................................................................................................................................... 2-43
Valve Assembly ........................................................................................................................................ 2-45
Sensor System ................................................................................................................................................... 2-48
Pressure Sensors ....................................................................................................................................... 2-48
Reservoir Level Sensors ............................................................................................................................ 2-52
Reservoir Management ............................................................................................................................ 2-55
Fluid Sensors ........................................................................................................................................... 2-56
Return Line Air Detector ......................................................................................................................... 2-58
Set ID Detector ....................................................................................................................................... 2-60
RBC Detector .......................................................................................................................................... 2-63
Fluid Leak Detector ................................................................................................................................. 2-66
Linear Actuator System .................................................................................................................................... 2-68
AIM System ..................................................................................................................................................... 2-71
Camera System ........................................................................................................................................ 2-71
Lighting System ....................................................................................................................................... 2-73
Centrifuge System ............................................................................................................................................ 2-81
Centrifuge Drive Assembly ...................................................................................................................... 2-85
Filler Assembly ......................................................................................................................................... 2-87
Centrifuge Motor Controller ................................................................................................................... 2-89
Mechanical System ........................................................................................................................................... 2-92
Dual IV Pole ............................................................................................................................................ 2-92
Wheel and Brake System ......................................................................................................................... 2-95
3: Software Description
Software Description .......................................................................................................................................... 3-2
Base Layer Software States .................................................................................................................................. 3-4
Power Control State ................................................................................................................................... 3-4
Startup State .............................................................................................................................................. 3-7
T1 Pump Power Test State ...................................................................................................................... 3-12
T1 Device Test State ............................................................................................................................... 3-14
T1 APC Test State ................................................................................................................................... 3-16
T1 Centrifuge Power Test State ............................................................................................................... 3-18
Load Disposable State .............................................................................................................................. 3-21
RBC Detector Calibration State .............................................................................................................. 3-26
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Disconnect Test State .............................................................................................................................. 3-28
Unload Disposable State .......................................................................................................................... 3-30
Set Layer Software States .................................................................................................................................. 3-32
Collection States ...................................................................................................................................... 3-32
Exchange States ....................................................................................................................................... 3-54
Protocol Layer Software States .......................................................................................................................... 3-77
MNC Run State ...................................................................................................................................... 3-77
RBCX Run State ..................................................................................................................................... 3-82
TPE Run State ......................................................................................................................................... 3-88
4: Troubleshooting
Non-Alarm Troubleshooting .............................................................................................................................. 4-2
Touchscreen Troubleshooting ................................................................................................................... 4-2
General AIM Troubleshooting ................................................................................................................... 4-3
Troubleshooting Failures During Start Up ................................................................................................ 4-5
Datalog Files ...................................................................................................................................................... 4-7
Alarm Troubleshooting ...................................................................................................................................... 4-8
Spectra Optia Alarms ....................................................................................................................................... 4-11
AC fluid detector detected fluid too soon. ................................................................................................ 4-12
AC fluid detector did not detect fluid. ..................................................................................................... 4-14
AC infusion data was invalid. ................................................................................................................... 4-16
AC infusion data was invalid. ................................................................................................................... 4-17
AC occlusion test failed. ........................................................................................................................... 4-18
AC pump did not stop when commanded. .............................................................................................. 4-20
AC pump malfunctioned. ........................................................................................................................ 4-22
AC pump software error occurred. ........................................................................................................... 4-24
AC pump speed was too high. ................................................................................................................. 4-25
AC pump turned faster than inlet pump. ................................................................................................. 4-26
AC volume limit was exceeded. ................................................................................................................ 4-28
AC was not detected. ............................................................................................................................... 4-29
AIM subsystem failed. .............................................................................................................................. 4-31
AIM system's interface measurement data was not updated. .................................................................... 4-33
AIM system could not establish target interface. ...................................................................................... 4-35
AIM system detected RBC interface near top of channel. ........................................................................ 4-37
AIM system did not complete calibration test. ......................................................................................... 4-40
AIM system did not complete channel imaging test. ................................................................................ 4-42
AIM system did not complete illumination test. ...................................................................................... 4-44
AIM system did not complete interface measurement. ............................................................................. 4-46
AIM system did not detect interface. ....................................................................................................... 4-48
AIM system did not respond to system command. ................................................................................... 4-51
AIM system failed calibration test. ........................................................................................................... 4-53
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AIM system failed channel imaging test. .................................................................................................. 4-55
AIM system failed illumination test. ........................................................................................................ 4-58
AIM system failed to measure interface. ................................................................................................... 4-61
Air may not have been removed from return line. .................................................................................... 4-64
Air removal is complete. ........................................................................................................................... 4-66
Air was detected in return line. ................................................................................................................ 4-67
Analog sensor data was not available. ....................................................................................................... 4-69
Bolus volume caused fluid balance to exceed limits. ................................................................................. 4-70
Calculation of pump rpm was not consistent. .......................................................................................... 4-72
Canceling custom prime recommendation. .............................................................................................. 4-74
Cassette mechanism that raises and lowers cassette malfunctioned. .......................................................... 4-75
Cassette sensor malfunctioned. ................................................................................................................ 4-77
Cassette software error occurred. .............................................................................................................. 4-79
Cassette tray was not correctly positioned. ............................................................................................... 4-80
Cassette was not detected in all positions. ................................................................................................ 4-82
Cassette was not lowered. ......................................................................................................................... 4-84
Centrifuge control malfunctioned. ........................................................................................................... 4-85
Centrifuge did not stop during alarm. ...................................................................................................... 4-87
Centrifuge did not stop when commanded. ............................................................................................. 4-88
Centrifuge door lock malfunctioned. ....................................................................................................... 4-90
Centrifuge door lock power circuit failed. ................................................................................................ 4-91
Centrifuge door lock sensor malfunctioned. ............................................................................................. 4-92
Centrifuge door lock software error occurred. .......................................................................................... 4-94
Centrifuge door lock test malfunctioned. ................................................................................................. 4-95
Centrifuge door position sensor malfunctioned. ....................................................................................... 4-97
Centrifuge door was not closed. ............................................................................................................... 4-99
Centrifuge door was opened or unlocked when centrifuge was spinning. ............................................... 4-100
Centrifuge exceeded maximum allowed speed. ....................................................................................... 4-102
Centrifuge motion detected was improper. ............................................................................................ 4-104
Centrifuge power could not be disabled. ................................................................................................ 4-106
Centrifuge power could not be enabled. ................................................................................................. 4-107
Centrifuge power did not turn off. ......................................................................................................... 4-108
Centrifuge pressure exceeded limit. ........................................................................................................ 4-110
Centrifuge pressure sensor failed calibration test. ................................................................................... 4-113
Centrifuge pressure sensor failed post-load test. ..................................................................................... 4-115
Centrifuge pressure sensor failed zero differential test. ............................................................................ 4-117
Centrifuge pressure sensor failed zero limit test. ..................................................................................... 4-119
Centrifuge pressure sensor failed zero range test. .................................................................................... 4-121
Centrifuge pressure sensor malfunctioned. ............................................................................................. 4-123
Centrifuge software error occurred. ........................................................................................................ 4-125
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Centrifuge speed sensors malfunctioned. ................................................................................................ 4-126
Centrifuge speed was not sufficient. ....................................................................................................... 4-128
Centrifuge speed was too high while procedure was paused. .................................................................. 4-130
Centrifuge was commanded to spin during alarm. ................................................................................. 4-132
Centrifuge was spinning in reverse. ........................................................................................................ 4-133
Chamber took too long to fill. ............................................................................................................... 4-135
Change replacement fluid to RBC for exchange. .................................................................................... 4-137
Change to patient data caused fluid balance to exceed limits. ................................................................. 4-138
Check connection from return line to blood warmer tubing. ................................................................. 4-141
Clamp inlet and return lines. ................................................................................................................. 4-142
Clamp inlet line. .................................................................................................................................... 4-143
Clamp return line. ................................................................................................................................. 4-144
Clamp return line. ................................................................................................................................. 4-145
Clear saline from drip chamber. ............................................................................................................. 4-146
Close inlet saline line. Clamp return line. .............................................................................................. 4-147
Close lines to prepare for tubing set test. ................................................................................................ 4-148
Close return saline line. .......................................................................................................................... 4-149
Close return saline line. .......................................................................................................................... 4-150
Close saline lines and clamp extra remove line. ...................................................................................... 4-151
Collection bag reached capacity. ............................................................................................................ 4-152
Collect recirculation flow path was not primed. ..................................................................................... 4-153
Confirming selection to begin rinseback. ............................................................................................... 4-155
Confirming selection to disable AIM system. ......................................................................................... 4-156
Confirming selection to disable RBC detector. ...................................................................................... 4-157
Confirming selection to disconnect patient and raise cassette. ................................................................ 4-158
Confirming selection to disconnect patient and raise cassette. ................................................................ 4-159
Confirm return line did not contain air. ................................................................................................ 4-160
Confirm saline lines were closed. ........................................................................................................... 4-161
Control flow was not consistent. ............................................................................................................ 4-162
Could not confirm saline lines were closed. ............................................................................................ 4-163
Current run targets could not be attained with run value entered. ......................................................... 4-164
Current run targets could not be attained with value entered. ................................................................ 4-165
Current run targets could not be attained with value entered. System paused. ....................................... 4-166
Custom prime volume was not sufficient. .............................................................................................. 4-167
Door-closed sensor was not consistent. .................................................................................................. 4-168
Door lock sensor was not consistent. ...................................................................................................... 4-170
Fan 1 failed. ........................................................................................................................................... 4-172
Fan 1 malfunctioned. ............................................................................................................................. 4-174
Fan 2 failed. ........................................................................................................................................... 4-176
Fan 2 malfunctioned. ............................................................................................................................. 4-178
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Fan 3 failed. ........................................................................................................................................... 4-180
Fan 3 malfunctioned. ............................................................................................................................. 4-182
Fluid balance change caused fluid balance to exceed limits. .................................................................... 4-184
Fluid balance no longer exceeded limits. ................................................................................................ 4-186
Fluid leak detector failed self-test. .......................................................................................................... 4-188
Hall sensor and encoder in AC pump malfunctioned. ............................................................................ 4-189
Hall sensor and encoder in inlet pump malfunctioned. .......................................................................... 4-191
Hall sensor and encoder in plasma pump malfunctioned. ...................................................................... 4-193
Hall sensor and encoder in replace pump malfunctioned. ...................................................................... 4-195
Hall sensor and encoder in return pump malfunctioned. ....................................................................... 4-197
High-level reservoir sensor detected excess fluid. .................................................................................... 4-199
High-level reservoir sensor detected fluid too soon. ................................................................................ 4-202
High-level reservoir sensor did not detect fluid. ..................................................................................... 4-204
High-level reservoir sensor failed fluid check. ......................................................................................... 4-206
High-level reservoir sensor failed timing test. ......................................................................................... 4-208
High-level reservoir sensor malfunctioned. ............................................................................................. 4-210
Hypervolemia condition was possible. ................................................................................................... 4-212
Hypervolemia limit was exceeded. ......................................................................................................... 4-213
Hypovolemia condition was possible. .................................................................................................... 4-214
Hypovolemia limit was exceeded. .......................................................................................................... 4-216
Identification of tubing set did not match selected procedure. ............................................................... 4-217
Improper state transition occurred. ........................................................................................................ 4-219
Inlet:AC ratio data was invalid. .............................................................................................................. 4-220
Inlet:AC ratio data was invalid. .............................................................................................................. 4-221
Inlet:AC ratio was above maximum. ...................................................................................................... 4-222
Inlet:AC ratio was below minimum. ...................................................................................................... 4-223
Inlet line prime failed. ............................................................................................................................ 4-224
Inlet line was not clamped. .................................................................................................................... 4-225
Inlet pressure sensor failed calibration test. ............................................................................................. 4-226
Inlet pressure sensor failed post-load test. ............................................................................................... 4-228
Inlet pressure sensor failed zero differential test. ..................................................................................... 4-230
Inlet pressure sensor failed zero limit test. .............................................................................................. 4-232
Inlet pressure sensor failed zero range test. ............................................................................................. 4-234
Inlet pressure sensor malfunctioned. ...................................................................................................... 4-236
Inlet pressure was too low. ..................................................................................................................... 4-238
Inlet pump did not stop when commanded. .......................................................................................... 4-240
Inlet pump malfunctioned. .................................................................................................................... 4-242
Inlet pump software error occurred. ....................................................................................................... 4-244
Inlet saline line was obstructed. .............................................................................................................. 4-245
Inlet saline line was obstructed during rinseback. ................................................................................... 4-247
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Interface still took too long to establish. ................................................................................................. 4-248
Interface took too long to establish. ....................................................................................................... 4-251
Internal timing was not consistent. ........................................................................................................ 4-254
Leak was detected in centrifuge. ............................................................................................................. 4-256
LED sensor malfunctioned. ................................................................................................................... 4-259
Low-level reservoir sensor continued to detect excess fluid. .................................................................... 4-260
Low-level reservoir sensor detected air. ................................................................................................... 4-263
Low-level reservoir sensor detected excess fluid. ..................................................................................... 4-265
Low-level reservoir sensor detected fluid too soon. ................................................................................. 4-268
Low-level reservoir sensor did not detect fluid. ....................................................................................... 4-270
Low-level reservoir sensor failed timing test. .......................................................................................... 4-272
Low-level reservoir sensor malfunctioned. .............................................................................................. 4-274
Low-level reservoir sensor malfunctioned. .............................................................................................. 4-276
Low-level reservoir sensor malfunctioned. .............................................................................................. 4-278
Low-level reservoir sensor persisted in detecting excess fluid. ................................................................. 4-279
Minus twelve volt power supply was out of range. ................................................................................. 4-282
NVRAM safety test failed. ..................................................................................................................... 4-283
NVRAM test failed. ............................................................................................................................... 4-284
Open and close centrifuge door. ............................................................................................................ 4-285
Open inlet saline line. ............................................................................................................................ 4-286
Open return saline line. ......................................................................................................................... 4-287
Open saline lines. ................................................................................................................................... 4-288
Patient's fluid balance may be 10% higher than reported. ...................................................................... 4-289
Patient's fluid balance may be 10% lower than reported. ....................................................................... 4-291
Patient's fluid balance may be 15% higher than reported. ...................................................................... 4-293
Patient's fluid balance may be 15% lower than reported. ....................................................................... 4-295
Patient's fluid balance may be 5% higher than reported. ........................................................................ 4-297
Patient's fluid balance may be 5% lower than reported. ......................................................................... 4-299
Patient fluid balance may be lower than reported. .................................................................................. 4-301
Patient height was invalid. ..................................................................................................................... 4-303
Patient height was invalid. ..................................................................................................................... 4-304
Patient hematocrit data was invalid. ....................................................................................................... 4-305
Patient hematocrit data was invalid. ....................................................................................................... 4-306
Patient sex was invalid. .......................................................................................................................... 4-307
Patient sex was invalid. .......................................................................................................................... 4-308
Patient TBV was invalid. ....................................................................................................................... 4-309
Patient TBV was invalid. ....................................................................................................................... 4-310
Patient weight was invalid. ..................................................................................................................... 4-311
Patient weight was invalid. ..................................................................................................................... 4-312
Pause button was touched. ..................................................................................................................... 4-313
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Plasma bag reached capacity. .................................................................................................................. 4-314
Plasma pump did not stop when commanded. ....................................................................................... 4-315
Plasma pump malfunctioned. ................................................................................................................ 4-317
Plasma pump software error occurred. ................................................................................................... 4-319
Plasma recirculation flow path was not primed. ..................................................................................... 4-320
Plasma remove flow path was not primed. ............................................................................................. 4-322
Plasma valve malfunctioned. .................................................................................................................. 4-324
Plasma valve sensor malfunctioned. ........................................................................................................ 4-325
Plasma valve software error occurred. ..................................................................................................... 4-326
Plasma valve was not correctly positioned. ............................................................................................. 4-327
Predicted fluid balance exceeded limits. ................................................................................................. 4-328
Predicted procedure time exceeded 8 hours. ........................................................................................... 4-330
Prediction software malfunctioned. ........................................................................................................ 4-331
Pressure in collect line was too high. ...................................................................................................... 4-333
Pressure sensor 4 failed calibration test. .................................................................................................. 4-335
Pressure sensor 4 failed post-load test. .................................................................................................... 4-337
Pressure sensor 4 failed zero differential test. .......................................................................................... 4-339
Pressure sensor 4 failed zero limit test. ................................................................................................... 4-341
Pressure sensor 4 failed zero range test. .................................................................................................. 4-343
Prime saline has been diverted. Close return saline line. ......................................................................... 4-345
Prime saline was not diverted. ................................................................................................................ 4-346
Procedure configuration data was corrupt. ............................................................................................. 4-347
Procedure data error detected. ................................................................................................................ 4-348
Procedure data error detected. ................................................................................................................ 4-349
Procedure time exceeded 8 hours. .......................................................................................................... 4-350
Pump 1 failed rotation test. .................................................................................................................... 4-351
Pump 2 failed rotation test. .................................................................................................................... 4-353
Pump 3 failed rotation test. .................................................................................................................... 4-355
Pump 4 failed rotation test. .................................................................................................................... 4-357
Pump 5 failed rotation test. .................................................................................................................... 4-359
Pump did not function correctly. ........................................................................................................... 4-361
Pump motion detected was improper. ................................................................................................... 4-363
Pump power could not be disabled. ....................................................................................................... 4-364
Pump power could not be enabled. ........................................................................................................ 4-365
Pumps and centrifuge did not stop during alarm. .................................................................................. 4-366
Pumps continued to turn during alarm. ................................................................................................. 4-367
Pumps did not stop during alarm. .......................................................................................................... 4-368
Pumps have been paused for 10 minutes. ............................................................................................... 4-369
Pumps have been paused for 3 minutes. ................................................................................................. 4-370
Pumps were commanded to turn during alarm. ..................................................................................... 4-371
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Pumps were commanded to turn instead of stop. ................................................................................... 4-372
Pumps were paused for 3 minutes. ......................................................................................................... 4-373
Pumps were turned during alarm. .......................................................................................................... 4-375
RBC detector calibration error occurred. ............................................................................................... 4-376
RBC detector did not respond. .............................................................................................................. 4-378
RBC detector did not transmit data. ...................................................................................................... 4-380
RBC detector software error occurred. ................................................................................................... 4-382
RBC recirculation flow path was not primed. ........................................................................................ 4-383
RBC remove flow path was not primed. ................................................................................................ 4-385
RBC valve malfunctioned. ..................................................................................................................... 4-387
RBC valve malfunctioned. ..................................................................................................................... 4-388
RBC valve sensor malfunctioned. ........................................................................................................... 4-389
RBC valve software error occurred. ........................................................................................................ 4-390
RBC valve was not correctly positioned. ................................................................................................ 4-391
Read-type communication error from RBC detector occurred. .............................................................. 4-392
Recommending custom prime. .............................................................................................................. 4-394
Red blood cells were detected in collect line too soon. ........................................................................... 4-395
Red blood cells were detected in plasma line from centrifuge. ................................................................ 4-398
Remove bag reached capacity. ................................................................................................................ 4-401
Remove valve malfunctioned. ................................................................................................................ 4-402
Remove valve sensor malfunctioned. ...................................................................................................... 4-403
Remove valve software error occurred. ................................................................................................... 4-404
Remove valve was not correctly positioned. ............................................................................................ 4-405
Replacement fluid detector detected fluid too soon. ............................................................................... 4-406
Replacement fluid was not detected. ...................................................................................................... 4-408
Replace pump did not stop when commanded. ..................................................................................... 4-410
Replace pump malfunctioned. ............................................................................................................... 4-412
Replace pump software error occurred. .................................................................................................. 4-414
Reservoir did not contain enough fluid. ................................................................................................. 4-415
Reservoir sensors malfunctioned. ........................................................................................................... 4-416
Reservoir was full during air removal. .................................................................................................... 4-417
Return line air detector detected fluid too soon. ..................................................................................... 4-419
Return line air detector failed fluid check. .............................................................................................. 4-421
Return line prime failed. ........................................................................................................................ 4-423
Return line was not clamped during air removal. ................................................................................... 4-425
Return line was not primed. ................................................................................................................... 4-427
Return pressure sensor failed calibration test. ......................................................................................... 4-429
Return pressure sensor failed post-load test. ........................................................................................... 4-431
Return pressure sensor failed zero differential test. ................................................................................. 4-433
Return pressure sensor failed zero limit test. ........................................................................................... 4-435
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Return pressure sensor failed zero range test. .......................................................................................... 4-437
Return pressure was too high. ................................................................................................................ 4-439
Return pressure was too high when system was diverting saline. ............................................................. 4-441
Return pump did not stop. .................................................................................................................... 4-442
Return pump did not stop when commanded. ....................................................................................... 4-443
Return pump malfunctioned. ................................................................................................................ 4-445
Return pump malfunctioned. ................................................................................................................ 4-447
Return pump software error occurred. ................................................................................................... 4-449
Return pump speed was too high. .......................................................................................................... 4-450
Return pump turned too fast. ................................................................................................................ 4-452
Return saline line failed integrity test. .................................................................................................... 4-454
Return saline line was not closed during air removal. ............................................................................. 4-456
Return saline line was obstructed. .......................................................................................................... 4-458
Return saline line was obstructed during air removal. ............................................................................ 4-460
Run target will be attained before next collection phase. ........................................................................ 4-462
Safety system could not confirm position of collect valve. ...................................................................... 4-463
Safety system could not confirm valve position. ..................................................................................... 4-464
Safety system could not read backup configuration file. ......................................................................... 4-466
Safety system could not read default configuration file. .......................................................................... 4-467
Safety system could not read primary configuration file. ........................................................................ 4-468
Safety system detected air in return line. ................................................................................................ 4-469
Safety system detected air in return line. ................................................................................................ 4-470
Safety system detected excess AC infusion. ............................................................................................. 4-471
Safety system detected internal timing inconsistency. ............................................................................. 4-473
Safety system detected software communication error. ........................................................................... 4-475
Safety system detected that patient hematocrit was lower than minimum. ............................................. 4-477
Safety system detected too much fluid in collection bag. ........................................................................ 4-478
Safety system detected too much fluid in plasma bag. ............................................................................ 4-479
Safety system detected too much fluid in remove bag. ............................................................................ 4-480
Safety system detected valve open longer than expected. ........................................................................ 4-481
Safety system did not respond to power request. .................................................................................... 4-483
Safety system did not respond to request to turn off power. ................................................................... 4-484
Safety system did not respond to request to turn on power. ................................................................... 4-485
Safety system failed power test. .............................................................................................................. 4-486
Safety system failed start process. ........................................................................................................... 4-488
Safety system lost internal communication capability. ............................................................................ 4-490
Safety system stopped air removal. ......................................................................................................... 4-492
Saline lines were not closed. ................................................................................................................... 4-493
Saline line was obstructed. ..................................................................................................................... 4-494
Sixty-four volt power supply was out of range. ....................................................................................... 4-496
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Spectra Optia Apheresis System Service Manual
Software consistency error occurred. ...................................................................................................... 4-497
Software control data was not updated. .................................................................................................. 4-498
Software CRC failed. ............................................................................................................................. 4-500
Software memory for AIM system was not sufficient. ............................................................................. 4-501
Software memory for control system was not sufficient. ......................................................................... 4-502
Software memory for safety system was not sufficient. ........................................................................... 4-503
Software module was not consistent. ...................................................................................................... 4-504
Stop button was touched. ...................................................................................................................... 4-505
System cannot verify that patient was disconnected. .............................................................................. 4-506
System could not load correct software. ................................................................................................. 4-507
System could not read backup configuration file. ................................................................................... 4-508
System could not read default configuration file. ................................................................................... 4-509
System could not read primary configuration file. .................................................................................. 4-510
System did not correctly monitor AC infusion. ...................................................................................... 4-511
System malfunctioned when it raised or lowered cassette. ...................................................................... 4-513
System paused: Centrifuge door was not closed. .................................................................................... 4-514
System was reset. .................................................................................................................................... 4-516
System was reset. .................................................................................................................................... 4-518
System was reset. .................................................................................................................................... 4-520
TBV restricted volume available to confirm volume in reservoir. ........................................................... 4-521
Test of negative inlet pressure failed. ...................................................................................................... 4-522
Test of negative return pressure failed. ................................................................................................... 4-524
Timing discrepancy in low-level reservoir sensor occurred. .................................................................... 4-526
Too much AC was detected during prime. ............................................................................................. 4-528
Tubing set did not match selected procedure. ........................................................................................ 4-529
Tubing set failed dwell test for negative inlet pressure. ........................................................................... 4-531
Tubing set failed dwell test for negative return pressure. ........................................................................ 4-533
Tubing set failed dwell test for positive inlet pressure. ............................................................................ 4-535
Tubing set failed dwell test for positive return pressure. ......................................................................... 4-537
Tubing set failed test for negative inlet pressure. .................................................................................... 4-539
Tubing set failed test for positive inlet pressure. ..................................................................................... 4-541
Tubing set failed test for positive inlet pressure. ..................................................................................... 4-543
Tubing set failed test for positive return pressure. .................................................................................. 4-545
Tubing set failed test of negative return pressure. ................................................................................... 4-547
Tubing set identification error occurred. ................................................................................................ 4-549
Tubing set may have contained fluid. .................................................................................................... 4-552
Twelve volt power supply was out of range. ........................................................................................... 4-554
Twenty-four volt power supply was out of range. ................................................................................... 4-555
Unclamp return line. ............................................................................................................................. 4-556
Unclamp return line. ............................................................................................................................. 4-557
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Valve position error occurred. ................................................................................................................ 4-558
Vent bag contained fluid during prime. ................................................................................................. 4-560
Vent bag contained fluid during run. ..................................................................................................... 4-562
Verification test that patient was disconnected from inlet line failed. ..................................................... 4-564
Verification test that patient was disconnected from return line failed. ................................................... 4-565
Voltage of fluid leak detector was above normal range. .......................................................................... 4-566
Voltage of fluid leak detector was below normal range. .......................................................................... 4-567
Volume entered for custom prime was too low. ..................................................................................... 4-569
Volume in collection bag may be lower than reported. ........................................................................... 4-570
Write-type communication error to data logging subsystem occurred. ................................................... 4-572
Write-type communication error to RBC detector occurred. ................................................................. 4-573
5: Maintenance and Calibration
Maintenance and Calibration ............................................................................................................................. 5-2
Removing the Side Panels .......................................................................................................................... 5-2
Raising the Pump Panel ............................................................................................................................. 5-5
Removing the Linear Actuator ................................................................................................................... 5-8
Calibrating the Centrifuge Motor Controller ........................................................................................... 5-10
Making a Test Cassette ............................................................................................................................ 5-12
Positioning the Linear Actuator Sensors ................................................................................................... 5-14
Printer and FTP Connectivity .......................................................................................................................... 5-17
Connecting a Printer ............................................................................................................................... 5-18
Connecting a Computer .......................................................................................................................... 5-20
6: Spectra Optia Spare Parts
Literature Group ................................................................................................................................................ 6-2
Documentation Group ....................................................................................................................................... 6-2
Display Head Group .......................................................................................................................................... 6-3
Pump Panel Group ............................................................................................................................................. 6-4
Centrifuge Basin Group ..................................................................................................................................... 6-6
E-box Group ...................................................................................................................................................... 6-7
Seal Safe Group .................................................................................................................................................. 6-9
Exterior Parts Group ........................................................................................................................................ 6-10
Tools Group ..................................................................................................................................................... 6-11
Other Parts Group ........................................................................................................................................... 6-11
Software Group ................................................................................................................................................ 6-12
Software Multipack Group ............................................................................................................................... 6-14
xii
Spectra Optia Apheresis System Service Manual
7: Specifications
Specifications ...................................................................................................................................................... 7-2
Glossary
Index
Spectra Optia Apheresis System Service Manual xiii
xiv Spectra Optia Apheresis System Service Manual
Preface
The Spectra Optia Therapeutic Apheresis System Service Manual provides the information needed
to service and troubleshoot the system.
Spectra Optia Apheresis System Service Manual 15
Preface
Who Should Read This Manual
This manual is intended for CaridianBCT service technicians and employees, trained and qualified
customer technical staff, and CaridianBCT service partners.
How to Use This Manual
This manual is divided into sections that can be read and used separately.
Title Description
Operational
Description
System Description Describes the functional and electronic principles of the machine
Software Description Describes the software that the machine uses to operate.
Troubleshooting Describes non-alarm and alarm troubleshooting. Provides alarm text and alarm
Maintenance and
Calibration
Spare Parts Describes the spare parts available for the machine.
Describes the operating principles of the machine. Includes information about system
components, operator controls, disposables, and procedures.
information.
Describes maintenance and service procedures for the machine.
16 Spectra Optia Apheresis System Service Manual
1
Operational Description
Spectra Optia Apheresis System Service Manual 1-1
Operational Description
Operational Description
The Spectra Optia Apheresis System is a transportable, automatic blood component separator that
uses centrifugation and optical detection (automated interface management or AIM) to perform
exchange and collection procedures.
The apheresis system operator uses the Spectra Optia system’s touch screen to communicate with the
system. The operator follows the instructions on the screens to enter patient and procedure data,
load and prime the disposable tubing set, and perform and troubleshoot procedures. During the
procedure, the system displays detailed procedural information, enabling the operator to adjust
values to achieve a specific outcome or troubleshoot a condition. After the procedure, the system
provides a summary of procedure data for the patient record. The operator may copy the data from
the screen, or print the data if the system is connected to a printer or a computer.
1-2 Spectra Optia Apheresis System Service Manual
System Components
System Components
The Spectra Optia system components include the video display, front panel, centrifuge chamber,
and electronics compartment.
Figure 1-1: Spectra Optia system, front and back views
Table 1-1: Spectra Optia System Components
Component Function
1 Monitor with touch screen Allows you to communicate with the system.
2 Dual IV pole Contains hooks for hanging bags and containers. Adjusts up and
down for transport.
3 Front panel Holds the pumps, valves, sensors and detectors.
4 Seal Safe system Seals the lines of the tubing set.
5 Cassette tray Holds the tubing set cassette in place.
Spectra Optia Apheresis System Service Manual 1-3
Operational Description
Table 1-1: Spectra Optia System Components (continued)
Component Function
6 Power switch Allows you to turn power to the system on and off.
7 View port Allows you to look through the centrifuge door to see the interface
in the channel.
8 Centrifuge door Allows access to the centrifuge chamber.
9 Wheel pedal Allows you to adjust the direction of the wheels for moving the
system, or lock the wheels in place so that the system does not roll.
10 Wheels Used to transport the system.
11 Handle wheels (2) Facilitates transport of the system in a horizontal position.
12 System serial number Unique number that identifies the system.
13 IV pole release button Allows you to lower the IV pole by pressing the button.
14 Power cord Connects the system to a power source.
15 Power cord holder Secures the power cord during transport.
16 Ethernet connection Allows you to connect the system to a printer or a computer to print
a procedure report.
17 Blood warmer bracket (not
shown)
Holds the blood warmer, if used.
1-4 Spectra Optia Apheresis System Service Manual
Modes of Operation and Procedure States
Modes of Operation and Procedure States
The Spectra Optia system has three modes of operation: Automatic mode, Semi-Automatic and
Service mode. In Automatic mode, the AIM system controls the interface. While in Semi-Automatic
mode, AIM system control of the interface is disabled. There are nine procedure states that perform
many individual steps to complete a procedure.
Automatic Mode
During Automatic mode, the system uses configured parameters and entered data to set and control
the pump flow rates, centrifuge speed, packing factor, run targets, and establish the interface. For
optimal separation in the channel, the target packing factor is 20. The system then uses feedback it
receives from the AIM system to control the interface, so it can collect a specific blood component
and return the rest to the patient.
Semi-Automatic Mode
During Semi-Automatic mode, the operator monitors the interface and adjusts it, as needed. The
system displays the interface on the screen, but does not control it. When certain alarm conditions
occur, you may be required to disable the AIM system before you continue the procedure in SemiAutomatic mode. Under those conditions, the interface position does not appear on the screen and
you must use the viewport to see the interface.
Service Mode
Service mode allows technicians to connect to the Spectra Optia system using service software for
troubleshooting and maintenance.
Procedure States
The procedure states listed in the following table describe system activity from the perspective of the
operator. For specific information on the software states, see the Software Description section of this
manual.
Table 1-2: Procedure States
State Description
Load Operator selects the procedure and loads the
appropriate tubing set.
Tubing set test System verifies that the correct tubing set is loaded
properly, and confirms the function of the pumps,
valves, and sensors.
Prime System primes the tubing set to remove air from the
set, and performs volumetric tests.
Spectra Optia Apheresis System Service Manual 1-5
Operational Description
Table 1-2: Procedure States (continued)
State Description
Run Patient is connected, and the system performs
apheresis, according to the selected procedure.
Rinseback System returns the blood remaining in the tubing set to
the patient after the run is complete to reduce the
patient’s RBC loss. Operator may choose to perform or
skip rinseback.
Disconnect test System verifies that the lines to the patient are clamped
before it raises the cassette.
Unload System raises the cassette and unloads the pumps.
Procedure summary System displays the final procedure values.
Next procedure System prepares for the next procedure.
1-6 Spectra Optia Apheresis System Service Manual
User Interface
User Interface
The Spectra Optia system’s user interface allows you to perform, adjust, and monitor procedures.
Navigating the Screen
Figure 1-2: Example screen
Table 1-3: User Interface elements
Section Description
1 Menu bar Contains menu buttons that you touch to show or hide menu tabs.
2 Menu tabs Appear according to the menu button that you touch. Tabs provide
access to screens that allow you to view information or modify the
procedure.
Spectra Optia Apheresis System Service Manual 1-7
Operational Description
Table 1-3: User Interface elements (continued)
Section Description
3 Message bar Displays information about what is currently occurring, and
occasionally displays instructions.
4 Activity area Displays tasks to complete, buttons that allow you to
• Navigate to another screen
• Change procedure conditions
• Change values or information about the procedure.
5 Action bar Contains buttons that you touch to perform the action stated on the
button, or to navigate to a different screen.
Screen Colors
The Spectra Optia system uses a color scheme to indicate the different states and conditions of the
procedure, allowing you to quickly determine the progress of the procedure.
Table 1-4: Corresponding color schemes for operating states and conditions
State or Condition Color
Load, prepare procedure, tubing set test, prime (patient
not connected)
Run, rinseback, disconnect test (patient connected)
Unload, procedure summary, next procedure (patient
disconnected)
Caution
Screen Buttons
Table 1-5: Active and Inactive Buttons
Active button
Active buttons are colored and
appear raised. Touch an active
button to enter, change, or save
data, or to proceed to the next
activity or action.
Inactive button
1-8 Spectra Optia Apheresis System Service Manual
Inactive buttons are gray. They
represent an action or information
that is not available.
User Interface
The buttons and icons described in the following table appear on the monitor or the screens, and
either allow you to operate and adjust the Spectra Optia system during an apheresis procedure, or
communicate important information.
Table 1-6: Button and Icons
Graphic Description Location Function
Go back button Bottom right side of the
screen
Mute button Bottom left side of the
screen
Pause button Bottom right corner of the
monitor
Stop button Bottom left corner of the
monitor
Returns you to the
previous screen. Available
only when it is safe to
return to the previous
screen. You must confirm
any data you changed
before touching the go
back button or the data
will not be saved.
Allows you to mute the
sound during an alarm
condition. The sound is
restored if another alarm
occurs.
Pauses the pumps.
Stops the centrifuge and
the pumps.
Active alarm button Bottom left side of the
screen Indicates an active
alarm.
Clock button Run and the exchange
status screens
Up/down arrow button Main run screen Allows you to adjust the
Spectra Optia Apheresis System Service Manual 1-9
Takes you to the active
alarm screen, or to a list
of active alarms if more
than one has occurred.
Allows you to view clock
time or elapsed time for
the procedure.
position of the interface
during Semi- Automatic
mode.
Operational Description
Table 1-6: Button and Icons (continued)
Graphic Description Location Function
Left/right arrow button Strobe screen Adjusts the timing of the
strobe. Allow you to view
different areas of the
channel.
Up/down scroll button Active alarm, alarm
history, and report
screens
Left/right scroll button Alarm action screens Allows you to scroll
Check mark icon Buttons on the prepare
procedure screens
Do not connect patient
icon
Bottom right side of the
screens
Allows you to view
additional information on
the screen.
through the different
alarm action screens, so
you do not have to return
to the main alarm screen
to troubleshoot an alarm.
Indicates completion of a
required task, or confirms
a selection.
Safety feature that
reminds you that the
patient should not be
connected during the
current operating state.
Operator override icon Total Blood Volume
button on the data entry
screen
Semi-Automatic mode
icon
1-10 Spectra Optia Apheresis System Service Manual
Bottom right side of the
run screens
Indicates that the operator
entered the patient’s total
blood volume when
necessary, or instead of
using the volume that the
system calculated.
Indicates that the system
is operating in SemiAutomatic mode.
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